ABSTRACT
The Food and Drug Administration (FDA) is generally recognized as one of the, if not the, premier therapeutic agent gatekeepers among nations. Consequently, the pharmaceutical and medical library stacks are laden with journals and manuals devoted to drug development and instructions on how to run the FDA gauntlet to reach the jackpot of drug approval. However, little attention is paid to the regulation of excipients. A number of standard texts on the subject are exhaustive in their reviews, although they offer little on how this agency regulates excipients, an integral and essential part of drug development in the review process for drugs. We trust the following provides a window on our actions and thinking in this area.
